ERIKA BARRETT TECHNICIAN, BIOLOGICAL SAFETY OFFICE OF RADIATION, CHEMICAL & BIOLOGICAL SAFETY FRIDAY, OCTOBER 3 RD, 2014 Implementation of an Audit Program

Requirements for an Audit Program Good laboratory practice Several federal agencies require an audit program such as:  Occupational Safety & Health Administration  National Institute of Health  United States Department of Agriculture

Evaluation Planning (determining needs, meetings) Development (creating manuals, developing guides) Implementing (audits, visits) Report & Analysis (data analysis, drafting reports) Audit Program Process

Process Acceptance Obtain responsible individuals approval  Integrate them in the planning stages  Request comments on developed forms, documents and guidelines  Create a culture of collaboration Getting everyone to buy- in to the program will increase safety culture Senior Vice President for Research ORCBS = Office of Radiation, Chemical & Biological Safety ORCBS & Committees Principal Investigators Laboratory Workers

Self-Assessment Self-assessment guides for the researchers  “Audit Check Guides” Rooms Agent Inventory Workers Training Requirements Storage Work Practices PPE PPE = Personal Protective Equipment

Guidelines Publish forms, guidelines and reference documents in an accessible space  Tailor the documents to the community  Establish the priority of development (i.e. audit program 2.0)  Publish prior to beginning the audit program if possible

Implementing the Audit Program Once you have developed the program  Start with the highest risk laboratories first (e.g. Biosafety Level 3)  Then move down the levels Multi-auditor visits to create continuity Change the auditor for each lab each year Complete follow-up BSL3BSL2 BSL1 & Plant BSL = Biological Safety Level

History of the ORCBS Biological Safety Program Support staff of the Institutional Biosafety Committee was responsible for UA biological safety The University of Arizona was inspected by the NIH in April 2011 The Radiation Control Office became ORCBS The CDC inspected the Select Agent/Toxin Program in November 2011 Requirements of ORCBS after inspection  Develop a complete audit program  Provide training to every laboratory worker  Obtain knowledge of current research community NIH = National Institutes of Health, CDC = Centers for Disease Control & Prevention

History of the ORCBS Chemical Safety Program Risk Management was responsible for UA chemical safety ORCBS started laboratory chemical safety in Fall 2011  Staffed the new program  Evaluated and updated forms  Created an inspection checklist  “Compliance checks” for granting authorities The scope of registered laboratories expanded Currently developing database for full program use

Registration of a Laboratory ORCBS is notified of a research laboratory ORCBS communicates with the researchers  Protocol forms  Invitations to training Forms sent to committee and workers complete training Initial visit  Follow-up Annual audit  Follow-up Total Biological Safety Registrations: 273 Total Chemical Safety Registrations: 186 (Expected 500+)

Annual Audit Program Annual audit for all laboratories  Follow-up with any corrective measures Unannounced laboratory visit 6 months from annual audit  Follow-up with any corrective measures A summary report of every visit and a previous inspection history is provided to the Principal Investigator

Perceived Difficulties Real Difficulties Obtaining acceptance of the audit program Compliance Building relationships Transfer of responsibility to ORCBS Differences in prior safety training Departmental rules vary Clarity of regulations  MSDSs and inventory requirements are up to the individual programs Gaining compliance Difficulties for Implementation of Audit Program

Successes for Implementing an Audit Program Overall programs current to standard Increased safety culture Decrease in number of findings per audit  Mostly new findings with updates, not reoccurring problems Utilization of proactive communication Compliance increased

Time Requirement For a new laboratory from start to finish for the first year, our office spends  10 hours for biological safety  8 hours for chemical safety For biological safety, this amounts to  300 Approvals: 3,000 hours / 3 years About 16% of our time each year was dedicated to new approvals, 15% for established approvals

Top Findings of Micropipette Tips 2. Biohazard Labeling (Rooms & Equipment) 3. Centrifuge Cups

Biological Safety Chemical Safety 1. Standard Operating Procedures 2. Spill Kit 3. Autoclave 4. Centrifuge Cups 5. Micropipette Tips 1. Laboratory-specific training 2. General safety training 3. (Material) Safety Data Sheets 4. Inventory 5. Secondary containment for acids and bases Top Findings of 2012

Biological Safety Chemical Safety 1. Standard Operating Procedures 2. Training 3. Spill Kit 4. Centrifuge Cups 1. Laboratory-specific training 2. General safety training 3. (Material) Safety Data Sheets 4. Inventory 5. Particularly hazardous chemical storage Top Findings of 2013

Updates to the Audit Program When there is an update to regulations, the audit program should reflect the change  Raise awareness  Begin to recommend the update  Add requirement  Finalize expectations and evaluate effectiveness “Sharp-like” micropipette tip rule (non-federal) The Globally Harmonized System Training (federal)

Sharp-like Micropipettes Case Study The radioactive material program at the UA designated pipette tips of 1 mL or less as sharp-like Biological safety adopted this requirement Research  BMBL  Surveyed other campuses  IBC voted Integrated the change into training and audit program 12% 3.5% 3%

GHS: Case Study OSHA adopted the Globally Harmonized System in 2012 Required training for all laboratory workers by December 1 st, 2013 ORCBS created a web-based 15 minute training and quiz for laboratory workers to take Initial and 3 reminder s

Total Trained by 12/1/2013: 1840

The Future of ORCBS Program Both programs expect to be inspected by an outside agency within the next year  NIH for biosafety, OSHA for chemical safety  Freezer inventory Chemical safety plans to deploy the full program in 2015 Future Goals  Updated database  Going paperless  iPad program

Questions?